News: Studying Adherence

A study to evaluate the impact of blister packaging on compliance in diabetes patients will employ electronic packaging and poststudy focus groups with patients.

“There have been a lot of studies on adherence, but how useful and meaningful they are is under debate. Many previous studies have documented patients’ behavior,” said Carol Looney, program manager for the Centers for Education and Research on Therapeutics (CERT), University of Texas, MD Anderson Cancer Center, (Houston).

“We hope to get at the underlying behavioral aspects of adherence and learn from the patients what worked, what didn’t, and why [in the post study segment],” Looney reported at the Healthcare Compliance Packaging Council’s (HCPC) annual Symposium on Patient Compliance in New Brunswick, NJ.

Looney said that nonadherent behavior in diabetes treatment “has been well correlated with glycemic control and poor clinical outcomes. We know that the No. 1 reason people don’t take their medications is because they forget. We expect that the blister packaging will help with that.”

Diabetes patients face the difficulty of adhering to a long-term regimen, and a multitude of factors contribute to non-adherent behavior.

Looney noted that in 2005 The Centers for Disease Control and Prevention said one-fifth of Americans over age 60 have diabetes. A recent study by the American Diabetes Association found that people with diabetes have medical expenditures about 2.3 times higher than people without the disease.

The six-month Houston CERT study will enroll 160 patients with type 2 diabetes. A control group will use bottles with microelectromechanical systems (MEMS) caps. Two or three different style blister packs with chips for capturing when pills are removed will be used in the study’s intervention arm. A requirement that patients are taking at least one other drug besides metformin, such as an ACE inhibitor, statin, or aspirin, is another promising aspect of the study.

The study will track the adherence to all the drugs, which will be blistered and MEMS packaged. Patient surveying will evaluate how patients prioritize the use of different drugs.

“We have assumed that if a patient is adherent or nonadherent to one medication, that is how they will behave with all others,” she said. “But that has not really been explored. This study will more closely mimic real life.”

Adherence will be measured by three indicators: the e-blister and MEMS cap data, self-reported data, and clinical outcomes. Patients will be given questionnaires to report the percentage of medications they have taken in the previous one or two weeks.

“Self-reporting is a valid measure,” Looney said. “There is a high correlation when patient self-reporting is compared with lab findings. [But] we do know that patients tend to overinflate their adherence.”

Clinical outcomes for glycosylated hemoglobin levels, blood pressure, and lipids will be measured at two-, four-, and six-month intervals.

In support of the study, HCPC is funding the medications, with companies including MeadWestvaco and Stora Enso providing packaging.

The Houston CERT is one of 11 CERT programs administered by the Agency for Healthcare Research and Quality. The congressionally mandated program conducts research and provides education on the optimal use of therapeutics.